Rx-360 is an International Pharmaceutical Supply Chain consortium. The individuals developing this concept are working in the best interest of patients. We are a non-profit organization that depends on volunteers to be successful. Our mission is to create and monitor a global quality system that meets the expectations of industry and regulators that assures patient safety by guaranteeing product quality and authenticity throughout the supply chain.
Recent highly publicized events have highlighted a weakness in the pharmaceutical supply chain. Significant harm to patients, including death, has been associated with these events. Examples include:
1. Adulterated glycerin with diethylene glycol (antifreeze) used to manufacture cough syrup has led to 67 deaths in Panama and 103 deaths in Haiti (mostly children).
2. Adulterated Heparin with hypersulfated chondroitin sulfate led to 81 deaths in the US and Europe.
3. Adulterated milk with melamine has led to contaminated infant formula causing kidney stones and deaths of infants in China.
4. Adulterated glycerin with diethylene glycol used to manufacture teething gel has led to over 40 infant deaths in Nigeria.
5. The World Health Organization (WHO) estimates that 10% of all medicines around the world are counterfeit. In addition it estimates that up to 30% of medicines sold in developing countries may be counterfeit, and some studies conclude that the percentage may be even higher.
Management of the pharmaceutical supply chain has become one of the top public health concerns with respect to consumer safety. The globalization of distribution for both drug components and finished products has introduced many complications that to date have yet to be resolved. Unethical players and noncompliant companies along the supply chain can introduce counterfeited, adulterated and contaminated materials, often with tragic consequences. Naturally, such incidents lead to a loud and swift reaction from the public, the health authorities and the policy makers.
As regulators, pharmaceutical executives, supplier executives and members of professional organizations, our ultimate mission is to serve patients. Millions of people around the world are treated everyday with the vital medicines that we collectively provide. That is what we do. However, the threats to the supply chain have not only prevented us from treating patients, but have caused the deaths of hundreds if not thousands of the individuals we are trying to serve.
In order to achieve this mission, we require secure and reliable supply chains that deliver the right materials at the right quality so that these vital medicines can be trusted by health care practitioners and patients.
Legislators, regulators, and other organizations around the world are developing and implementing local measures to curtail these activities or mitigate their impact. A global consortium will complement these efforts and deliver a level of consistency and scope world-wide, that local measures cannot achieve.